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MDACS Activities

MDACS Activities

Replacing the term “Make” with “Manufacturer” under the Medical Device Administrative Control System (MDACS)

28 Mar 2024

Starting from 2 April 2024, the term “Make” has been replaced with “Manufacturer” under MDACS. The definition of “Manufacturer” stipulated in Guidance Notes GN-00 remains unchanged.

The following updated Guidance Notes, Code of Practice and Forms in response to the above changes are uploaded to our website (www.mdd.gov.hk):

  • Guidance Notes: GN-01, GN-02, GN-03, GN-04, GN-06, GN-07, GN-08, GN-09
  • Code of Practice: COP-01, COP-02, COP-03, COP-04, COP-05
  • Forms: MD-IP+D, MD101, MD102, MD107, MD-CCL, MDIVD-CCL, AIR-LRP, MD108, MD-Renewal, MD110

 

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